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Prevnar for otitis media

Executive Summary

Wyeth's Prevnar otitis media indication cautions that vaccine is not as effective as its 100% protection against invasive pneumococcal disease. "Protection against otitis media is expected to be substantially lower than protection against invasive disease." Prevnar's estimated otitis media efficacy against vaccine serotypes is 57%, while efficacy regardless of etiology is 6%. The wording of the indication reflects recommendations by FDA's Vaccine & Related Biological Products Advisory Committee ("The Pink Sheet" May 27, p. 30). FDA approved Prevnar for otitis media Oct. 1; Wyeth received a "complete response" letter in May 2001. Prevnar has been in shortage since fall 2001...
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PS040698

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